Judge Eifert said that that J&J’s Ethicon unit acted negligently in destroying or losing thousands of documents and files relating to the development of its vaginal-mesh implants. Gaps in the data reportedly go back as far as 2007. The data relates to vaginal mesh products Gynecare Prolift and TVT Retropubic sling, which were developed for surgical implantation in women who suffered from weakened pelvic walls. Some vaginal mesh lawsuits have been settled and total awards in the millions.
Ethicon did not dispute Judge Eifert’s finding at the pre-trial hearing. Ethicon officials admitted that their protocols for document-retention had “failed miserably in certain instances.” However, it must now be determined whether the jury hearing the class action, which represents some 12,000 personal injury lawsuits, should hear about the lost documentation, as it could sway their verdict.
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Johnson & Johnson's Gynecare Mesh is not the only to face allegations of serious injury. Various mesh products, including Avaulta vaginal mesh, have been linked to serious side effects. Those include migration of the mesh, pain, inflammation and other health problems. Some women have undergone surgery to have the mesh removed. In January, 2012, the FDA sent letters to 35 surgical mesh makers ordering new safety studies on the products.